Medline medical convenience kits, labeled as recallZ-2997-2026 · Medline Industries, LP · initiated Jul 8, 2026
Class II Open, Classified All recalls posted in August 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/8/2026 via USPS and email. The notice explained the issue, potential adverse health consequences, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-112-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or [email protected].
Recall details
- Recall number
- Z-2997-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 8, 2026
- Posted by the FDA
- Aug 21, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 974 kits
- Product code
- OJH
- Distribution
- US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
Product description
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.
Code information (models, lots, serial numbers)
Show the full code information (3k characters)
Medline Kit SKU DYNJT6548, UDI/DI 10198459558764 (each) 40198459558765 (case), Lot Number 25JMF561; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDA305; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDB254; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMF418; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMJ129; Medline Kit SKU DYNJ46024F, UDI/DI 10195327237011 (each) 40195327237012 (case), Lot Number 23HBJ773; Medline Kit SKU DYNJ54479C, UDI/DI 10193489460254 (each) 40193489460255 (case), Lot Number 23HBA720; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23BMC930; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23FMD505; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23JMH313; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23LME066; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 22CMG565; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 24BME326; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 24EMF925; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23AMJ184; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23EMD739; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23IME138; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23KMB648; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23LMB107; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 23LMH426; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 22FMF374; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case), Lot Number 22KMH219; Medline Kit SKU DYNJ83585, UDI/DI 10195327283179 (each) 40195327283170 (case), Lot Number 23HMC695; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 25CMD816; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 24IMD021; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case), Lot Number 24IME838; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case), Lot Number 23IBJ627; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case), Lot Number 23IBL564; Medline Kit SKU PHS396933009C, UDI/DI 10193489753301 (each) 40193489753302 (case), Lot Number 22EDB595
Devices named in this recall
10 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ54479CMedline Industries, Inc. · Orthopedic tray4 recalls0 reports
- Medline Industries, Inc. DYNJ46024FMedline Industries, Inc. · Orthopedic tray4 recalls0 reports
- Medline Industries, Inc. DYNJ45419FMedline Industries, Inc. · Orthopedic tray3 recalls0 reports
- Medline Industries, Inc. PHS396933009CMedline Industries, Inc. · Orthopedic tray2 recalls0 reports
- Medline Industries, Inc. DYNJ58014AMedline Industries, Inc. · Orthopedic tray2 recalls0 reports
- Medline Industries, Inc. DYNJ900467IMedline Industries, Inc. · Orthopedic tray2 recalls0 reports
- Medline Industries, Inc. DYNJ83585Medline Industries, Inc. · Orthopedic tray2 recalls0 reports
- Medline Industries, Inc. DYNJ44504GMedline Industries, Inc. · Orthopedic tray2 recalls0 reports
- Medline Industries, Inc. DYNJ58006BMedline Industries, Inc. · Orthopedic tray1 recall0 reports
- Medline Industries, Inc. DYNJ88056Medline Industries, Inc. · Orthopedic tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99489).
- Z-2994-2026 · Open, ClassifiedMedline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; …
- Z-2995-2026 · Open, ClassifiedMedline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU…
- Z-2996-2026 · Open, ClassifiedMedline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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